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Alagille Syndrome

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July 25, 2024
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FDA expands Livmarli approval for pruritus in PFIC to infants as young as 12 months

FDA expands Livmarli approval for pruritus in PFIC to infants as young as 12 months

The FDA has updated the label indication for Livmarli for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis, expanding the patient population to include infants aged 12 months and older.

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May 16, 2024
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ASSERT: Bylvay outperforms placebo in reducing pruritis, bile acids in Alagille syndrome

ASSERT: Bylvay outperforms placebo in reducing pruritis, bile acids in Alagille syndrome

Treatment with Bylvay resulted in a “significantly greater” change from baseline to week 24 in mean scratching scores and serum bile acids vs. placebo among pediatric patients with Alagille syndrome, according to ASSERT study results.

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March 14, 2024
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FDA approves Livmarli for pruritus in progressive familial intrahepatic cholestasis

FDA approves Livmarli for pruritus in progressive familial intrahepatic cholestasis

The FDA has approved Mirum Pharmaceuticals’ Livmarli oral solution for treatment of cholestatic pruritus in patients aged 5 years and older with progressive familial intrahepatic cholestasis, according to a company release.

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February 29, 2024
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‘Show your stripes:’ Rare Disease Day allows patients to share their stories, spread awareness

‘Show your stripes:’ Rare Disease Day allows patients to share their stories, spread awareness

More than 300 million people worldwide, including one in every 10 Americans, are living with a rare disease, yet these individuals and their families are often left isolated and without answers.

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June 23, 2023
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VIDEO: Livmarli reduces serum bile acids and pruritus in PFIC, Alagille syndrome

VIDEO: Livmarli reduces serum bile acids and pruritus in PFIC, Alagille syndrome

In a Healio video exclusive, Pam Vig, PhD, highlights new data on Livmarli for the treatment of patients with pruritus due to progressive familial intrahepatic cholestasis and Alagille syndrome, which were presented at EASL Congress.

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June 13, 2023
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FDA approves Bylvay for cholestatic pruritus due to Alagille syndrome

FDA approves Bylvay for cholestatic pruritus due to Alagille syndrome

The FDA has approved Bylvay for the treatment of cholestatic pruritus due to Alagille syndrome in patients aged 12 months or older, according to an Ipsen Biopharmaceuticals press release.

News
March 15, 2023
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FDA expands Livmarli label to include infants with pruritus aged 3 months or older

FDA expands Livmarli label to include infants with pruritus aged 3 months or older

The FDA has approved labeling changes for Livmarli, reducing the age of prescribing to infants with Alagille syndrome from 1 year to 3 months for the treatment of cholestatic pruritus, according to a Mirum Pharmaceuticals press release.

News
December 17, 2022
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European Commission approves Livmarli for patients with Alagille syndrome

European Commission approves Livmarli for patients with Alagille syndrome

Mirum Pharmaceuticals announced the European Commission has approved Livmarli for the treatment of cholestatic pruritis in patients with Alagille syndrome.

News
November 07, 2022
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VIDEO: Bylvay improves pruritus, reduces serum bile acids in Alagille syndrome

VIDEO: Bylvay improves pruritus, reduces serum bile acids in Alagille syndrome

WASHINGTON D.C. — In a Healio video exclusive, Ron Cooper, CEO of Albireo Pharma, highlighted positive top-line safety and efficacy results of Bylvay for the treatment of Alagille syndrome in patients from birth to early adulthood.

News
January 30, 2021
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FDA accepts new drug application for pruritis treatment odevixibat

The FDA accepted a new drug application for odevixibat for the treatment of pruritis in patients with progressive familial intrahepatic cholestasis, according to a press release.

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